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Clinical Site Manager, Arkansas Children's Research Institut

at Arkansas Childrens in Little Rock, Arkansas, United States

Job Description

Work Shift:

Day Shift

Time Type:

Full time

Department:

CC038974 Snowden DCOC Staffing account

Summary:

Maintains thorough knowledge of clinical trial protocols and accompanying documents, databases, and clinical research site status for a national clinical research network. Provides consultation and guidance to research sites, reviews protocol conduct, reviews study site electronic data entry for complete and correct data collection, creates data queries for site review and response. Works with sites to report protocol deviations accurately, and follows up on corrective actions. Ensures all adverse events, serious AEs and unexpected problems are reported and coded accurately for safety purposes.

Required Education:

Bachelor’s degree from four-year college or university

Recommended Education:

Required Work Experience:

Related Field – 4 years of experience

Recommended Work Experience:

Required Certifications:

Recommended Certifications:

Certified Clinical Research Professional (CCRP) – Society of Clinical Research Associates

Description

1. Reviews research study progress for all sites.

2. Responds to request for information from all sites.

3. Conducts at least weekly site check-in’s.

4. Monitors each site’s protocol conduct, progress, timelines, reviews site electronic data entry for complete and correct data collection, and creates data queries for site review and response.

5. Provides consultation and guidance to sites on any questions.

6. Ensures site management activities are in compliance with Federal regulations and Good Clinical Practice.

7. Work with sites to report protocol deviations accurately.

8. Follows up on corrective actions.

9. Ensures all adverse events, serious AEs and unexpected problems are reported for safety purposes using safety event coding system to code each event for review by the safety team.

10. Prepares, reviews, and edits study materials that accompany the protocol (ex: Manual of Procedures, Laboratory manuals, Pharmacy Manuals). Assist in designing the content for study databases for accurate and complete data collection.

Arkansas Children’s is the only health system in the state solely dedicated to caring for children, which allows our organization to uniquely shape the landscape of pediatric care in Arkansas. Our system includes two hospitals, a pediatric research institute, a foundation, and several clinics across the state. For more than a century, Arkansas Children’s has continuously evolved to meet the unique needs of the children of Arkansas and beyond.

Our team members are focused on fulfilling a promise to define and deliver unprecedented child health. We are also united by a mission: We champion children to make them better today and healthier tomorrow.

Arkansas Children’s Hospital is among the elite 6 percent of hospitals globally that have Magnet Status (https://www.archildrens.org/about-us/magnet-recognition) . Our health system includes a 336-bed hospital in Little Rock with the state’s only pediatric Level 1 Trauma Center, burn center, Level 4 neonatal intensive care and pediatric intensive care, a research institute, and nationally recognized transport service. We are nationally ranked by U.S. News World Report in four specialties: (2021-2022): Cardiology & Heart Surgery, Nephrology, Pulmonology and Urology.

A sister campus, Arkansas Children’s Northwest, opened in February 2018, bringing 233,613 square feet of inpatient beds, emergency care, clinic rooms and diagnostic services to children in that corner of the state.

Generous philanthropic and volunteer engagement has sustained Arkansas Children’s since it began as an orphanage in 1912, and today ensures the system can deliver on its promise of unprecedented child health.

Arkansas Children’s provides equal employment opportunity to all persons without regard to age, race, color, religion, national origin or citizenship status, disability, military status, sexual orientation, gender identity or expression, pregnancy or any other category protected by federal, state and local laws. Further, Arkansas Children’s will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

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Job Posting: JC194336354

Posted On: Oct 08, 2021

Updated On: Dec 07, 2021